Q-linea is a public-listed diagnostic company that develops innovative solutions for improved infectious disease diagnostics, with a keen focus on improving sepsis treatment while reducing antibiotic resistance. The company focuses on developing instruments and consumables that benefit patients, healthcare providers and society.
Founded in Uppsala
Q-linea was founded in 2008 by scientists from the Rudbeck Laboratory at Uppsala University, together with Olink AB and Uppsala University’s holding company, UUAB. Today, Q-linea is a growing company comprises an interdisciplinary, highly motivated team of 100+ employees and consultants that operates out of state-of the-art, customised facilities in Uppsala Science Park and Fyrislund.
For more information, visit the company´s web site at http://www.qlinea.com
Vision & mission
As an innovative pioneer, Q-linea helps to save lives by ensuring antibiotics continue to be an effective treatment for future generations. Q-linea develops and delivers preferred solutions for healthcare providers, enabling them to accurately diagnose and treat infectious diseases in the shortest possible time. Our solutions help healthcare providers worldwide to reduce the use of antibiotics by providing optimal treatment information for each patient.
Job Title: Validation Engineer
Reports to: Manager QA/RA
Q-linea is an innovative research, development and manufacturing company that primarily develops instruments and disposables for rapid and reliable infection diagnostics.
Q-linea is looking for a Validation Engineer supporting all types of validation and qualification activities at the company including Process Validation, Equipment Qualification, QC method validation (i.e. analytical methods), Computer Systems Validation, Cleaning Validation, and validation of Facilities, Storage areas, etc.
We are looking for a motivated person with at least 2 years of experience in process validation from the Pharmaceutical or Medical Device industry. The person needs to be good in communication, both oral and written, having the ability to work across different teams, and good time management to drive performance.
Qualifications and experiences
• MSc or BSc degree within science (Biotechnology/Chemical/Quality) or engineering or experience from a similar position
• Experience (at least two years) of process validation within the Pharmaceutical or Medical Device industry
• Experience in documenting and performing process validation and equipment qualification
• Knowledge in the requirements of ISO 13485-standard or GMP
• Proficient in writing technical reports
• Excellent verbal and written communication skills in Swedish and English
• Skillful in analyzing data sets and performing relevant statistical analysis using software for e.g. Gage R&R, process capability is a merit
• Experience in process development and/or production of Medical Devices/Pharma is a merit
• Experience in developing Design of Experiments (DOEs) is a merit
• Experience of collecting process data and provide statistical analysis to generate status reports for process/QC performance is a merit
• Experience in process risk management is a merit
• Ability to multitask and meet deadlines
• Strong attention to details
• High level of self-motivation with the ability to operate independently and with minimum supervision when required
• Provides others with a clear direction
• Good communication, writing, and presentation skills in Swedish and English
• Ability to logically organize thoughts and ideas
• Work with a sense of urgency and having the ability to be unbiased and objective
• Ability to work across teams
• Good time management and meeting deadlines and commitments
• Ability to prioritize and manage multiple tasks
• Positive “can-do” attitude and a “doer”
Opportunities with the role
• To contribute to Q-linea’s very important mission; to help save lives by ensuring antibiotics continue to be an effective treatment for future generations
• The possibility to work for a very exciting Swedish Life Science company with a high growth rate and a huge potential to grow
• The possibility to work with very high quality, innovative and unique products that the society, healthcare and patients are asking for
• Q-linea offers continues development for all personnel, both individual and team oriented
• Work together with an experienced and very committed team, in a creative and very prestigeless environment
• The company culture is very attractive with a focus on community and development
• Be part of a successful expansive and dynamic company focusing on research, innovation and results to help the world to cover the threatening of antibiotic resistance
For more information and questions about the position, please contact; Marta Frick Senior Recruitment Consultant at PeakSearch.
Marta Frick email@example.com Tel: 070-386 89 69